FDA Sends Plan B Back to the Drawing Board

JULY 01, 2004

Ken Rankin

Community pharmacists will not be selling the controversial Plan B
emergency contraceptive OTCat least not this year. If the drug ever does
win approval for nonprescription status, pharmacists may be called on to
check the identity of purchasers.

Despite pressure from pro-choice groups to make the so-called "morningafter
pill" available to women without a prescription, FDA officials raised concerns
about the possible use of such a product by adolescent girls. In issuing a
"Not Approvable" letter to Plan B sponsor Barr Laboratories, the FDA said that
the company needs to conduct more research on the use of that product by
girls younger than 16. "The sponsor's application contained no data on subjects
under 14 years of age and very limited data on adolescents 14 to 16 years
old," the agency letter said.

The FDA letter also said that Barr's application failed to include "adequate
data to support use of Plan B by young adolescent women without the intervention
of a physician."

The manufacturer is working to address the FDA's concerns. It is expected
to issue a new proposal under which the drug would be sold OTC to
women 16 and older, but by prescription only to those under 16.